Ted Pharmaceuticals (03880) successfully completed the US FDA pre-marketing inspection (PLI) for HEPCLUDEX® raw materials

Zhitong Financial App News, Tide Pharmaceutical (03880) announced that the current production quality management specification (“cGMP”) production facility of China Peptide Biochemical Co., Ltd. (“China Peptide Biochemical”), a wholly-owned subsidiary of the company, has successfully passed the pre-marketing license inspection (“PLI”) carried out by the US Food and Drug Administration (“FDA”).

The strict on-site review, which was conducted from January 26 to February 3, 2026, comprehensively assessed the production facility's commercial production and operation of a complex fully chemically synthesized long-chain polypeptide ingredient (“API”) of 8.5 mg of injectable Hepcludex® (bulevirtide-gmod). The drug received accelerated approval from the US FDA on May 22, 2026, making it the first and only drug approved in the US to treat chronic hepatitis D virus (“HDV”) infection.

Dr. Li Xiang, Chairman of China Peptide Biochemical Co., Ltd., said, “With Hepcludex® receiving landmark accelerated approval from the US FDA, China Peptide Biochemical extends its warmest and most sincere congratulations to our strategic partner Gilead Sciences (Gilead Sciences). As a commercial API provider for this pioneering therapy, we are proud to witness and support this historic medical advance that has the potential to fundamentally change the treatment landscape for patients with chronic HDV.”